Off-The-Shelf Neoantigen Cancer Vaccine Candidate Launches Phase 1 Study

Nouscom NOUS-209 vaccine is expected to induce potent and broad CD8+ and CD4+ responses in humans
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(Precision Vaccinations)

A Switzerland based immuno-oncology company announced that the 1st patient has been dosed in a Phase 1 clinical trial evaluating its lead vaccine candidate, NOUS-209. 

In this first-in-human trial NOUS-209, an off-the-shelf therapeutic vaccine based on shared tumor neoantigens is being administered to patients with Microsatellite Instable High (MSI-H) gastric, colorectal and gastro-esophageal junction cancers, in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab.

Announced by a Nouscom press release on  December 9, 2019, the NOUS-209-01 open-label, dose-escalation study will evaluate vaccine-induced immune responses, as well as preliminary signs of anti-tumor activity in about 34 enrolled patients. 

The NOUS-209-01 study is composed of a Main-Study lasting 26 weeks and an Extended Follow-up from week 27 to week 106 of anti-PD-1 checkpoint inhibitor pembrolizumab SOC treatment and further 4 weeks following cessation of pembrolizumab treatment for safety follow-up until week number 110.

The initial clinical data are expected in 2020.

Based on preclinical data, NOUS-209 is expected to induce potent and broad CD8+ and CD4+ responses in humans said the company.

"We have seen tremendous change in our approach to MSI-high metastatic solid tumors over the last few years, but the majority of patients do not respond to single-agent immunotherapy,” said Dr. Michael J. Overman, Principal Investigator of the trial and Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center, in the press release.

“Hence, further optimization of our approach for MSI-high cancers is needed.” 

“Agents like NOUS-209 that stimulate the patient's immune response and direct it specifically against the cancer cells reflect a tremendous scientific evolution in our understanding of these cancers and represents an extremely promising approach for these cancers."

Dr. Elisa Scarselli, Chief Scientific Officer and Co-Founder of Nouscom, said: "NOUS-209 was named because it comprises 209 shared Frame Shift Peptides (FSPs) selected using a proprietary algorithm.” 

“This feature of NOUS-209 enables it to be developed as an off-the-shelf neoantigen vaccine that does not require patient screening prior to treatment.” 

“Furthermore, it is designed to have broad coverage across the MSI patient population by targeting multiple neoantigens in each patient, and as such is expected to address tumor heterogeneity.”

Nouscom is a privately-held oncology company headquartered in Basel, Switzerland with operations in Rome, Italy, developing next-generation immunotherapies. Nouscom's proprietary technology platform harnesses the full power of the immune response by combining viral vectored genetic vaccines based on neoantigens with other immunomodulators.

Cancer Vaccine news published by Precision Vaccinations